Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
Amgen Inc. (AMGN) and Wyeth |
Enbrel (FDA-approved) |
Etanercept; anti-TNF-alpha antibody |
All approved indications |
FDA approved once-weekly dosing of Enbrel across all indications (10/20) |
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Genentech Inc. (NYSE:DNA) and XOMA Ltd. (XOMA) |
Raptiva |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis |
Chronic moderate to severe plaque psoriasis in adults |
FDA approved Raptiva, a biologic injected once a week; XOMA will get about 25% of U.S. sales, which are expected to start by the end of November (10/27) |
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CANCER | ||||
Allos Therapeutics Inc. (ALTH) |
RSR13 |
Efaproxiral; radiation sensitizer |
Metastatic breast cancer |
Allos submitted to the FDA the second of three data components for its new drug application (10/2) |
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Aton Pharma Inc.* |
SAHA |
Histone deacetylase inhibitor |
Multiple myeloma |
FDA granted orphan designation to the product (10/13) |
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ILEX Oncology Inc. (ILXO) |
Clofarabine |
Second-generation purine nucleoside antimetabolite |
Refractory or relapsed acute pediatric leukemia |
ILEX submitted the first part of a rolling new drug application, and intends to complete the NDA filing in the first half of 2004 (10/22) |
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ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co. |
Erbitux |
Cetuximab; antibody designed to block EGFR |
Metastatic colorectal cancer |
FDA accepted for filing and review the BLA for Erbitux in combination with irinotecan for EGFR-expressing disease (10/10) |
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NeoRx Corp. (NERX) |
Skeletal targeted radiotherapy |
Targeted therapeutic consisting of small molecule and radionuclide |
Multiple myeloma |
NeoRx reached agreement with FDA on special protocol assessment for design of Phase III trial; it also said one trial would be sufficient for registration (10/1) |
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Sonus Pharmaceuticals Inc. (SNUS) |
Tocosol paclitaxel |
Re-formulation of the cancer drug |
Bladder cancer |
The FDA granted fast-track status to the product in treating inoperable transitional cell carcinoma of the urothelium (10/29) |
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Tularik Inc. (TLRK) |
T67 |
Small molecule that binds to beta-tubulin |
Unresectable hepatocellular carcinoma |
The FDA granted fast-track status to the drug in first-line therapy; the drug is being tested in a pivotal study (10/22) |
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CARDIOVASCULAR | ||||
Biopure Corp. (BPUR) |
Hemopure |
Hemoglobin glutamer - 250 (bovine) |
Anemia in orthopedic surgeries and reduction of blood cell tranfusions |
FDA had questions about the BLA for Hemopure; Biopure said collecting the data will take several months to complete (10/30) |
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CV Therapeutics Inc. (CVTX) |
Ranexa |
Ranolazine; partial inhibitor of fatty-acid oxidation |
Chronic angina |
FDA's Cardiovascular and Renal Drugs Advisory Committee will review Ranexa at its Dec. 9 meet- ing (10/23); FDA issued approvable letter indicating additional clinical information would be needed before gaining approval (10/30) |
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CENTRAL NERVOUS SYSTEM | ||||
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Alkermes Inc. (ALKS) and Johnson & Johnson |
Risperdal Consta |
Risperidone formulated in Alkermes' long-acting Medisorb technology |
Schizophrenia |
Risperdal Consta, which has been approved in more than 40 countries, was approved and will be sold in the U.S. by J&J unit Janssen Pharmaceutica Products LC (10/29) |
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Avigen Inc. (AVGN) |
AV201 |
Gene therapy that delivers the gene for AADC to help regulate dopamine levels |
Parkinson's disease |
The Recombinant DNA Advisory Committee recommended that Avigen could begin clinical testing of the product (10/20) |
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Cephalon Inc. (CEPH) |
Provigil (FDA-approved) |
Modafinil |
Improving wakefulness |
The FDA issued an approvable letter to broaden the label to include shift workers and those with obstructive sleep apnea/hypopnea syndrome; launch is expected in 1Q:04 (10/21) |
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DOV Pharmaceuticals Inc. (DOVP) |
Ocinaplon |
Modulates subset of GABA-A receptors |
Anxiety |
FDA placed hold on start of Phase III trial until more safety data are provided (10/2) |
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Endo Pharmaceuticals Inc. (subsidiary of Endo Pharmaceuticals Holdings Inc.; ENDP) |
Oxymorphone |
Extended- and immediate-release formulations of oxymorphone |
Pain |
FDA issued approvable letters for both products calling on company to provide additional information and conduct additional trials (10/20) |
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Neurobiological Technologies Inc. (NTII) and Forest Laboratories Inc. |
Namenda |
Memantine; NMDA receptor antagonist |
Moderate to severe Alzheimer's disease |
FDA approved the drug, which is expected to be available in January (10/17) |
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Pozen Inc. (POZN) |
MT 100 |
Tablet formulation |
Migraine |
Pozen said FDA accepted the NDA for filing; action is expected by June 2004 (10/7) |
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Pozen Inc. (POZN) and Xcel Pharmaceuticals Inc. * |
MT 300 |
Formulation of dihydroergotamine mesylate |
Migraine |
The FDA issued a non-approvable letter based on failure to achieve statistical significance on secondary endpoints at two hours 10/20) |
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INFECTION | ||||
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Tanox Inc. (TNOX) |
TNX-355 |
Humanized monoclonal CD4 molecule |
HIV |
FDA granted fast-track status in HIV patients who have failed or are failing antiretroviral therapy (10/9) |
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Vertex Pharmaceuticals Inc. (VRTX) and GlaxoSmithKline plc (UK) |
Lexiva |
Fosamprenavir calcium; protease inhibitor |
HIV infection |
The FDA approved Lexiva for the treatment of HIV infection in adults in combination with other antiretroviral drugs (10/21) |
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MISCELLANEOUS | ||||
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ISTA Pharmaceuticals Inc. (ISTA) |
Vitrase |
Ovine hyaluronidase |
Agent to facilitate absorption of other drugs |
ISTA said the FDA accepted for filing and review an NDA for the drug (10/7) |
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Savient Pharmaceuticals Inc. (SVNT) |
-- |
Sodium hyaluronate product |
Pain associated with osteoarthritis of the knee |
FDA issued approvable letter sub- ject to manufacturing inspection and labeling (10/8) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
NYSE = New York Stock Exchange. |